MAUDE Adverse Event Report: Vascutek LTD Gelweave Four Branch Plexus; Gelweave Plexus

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Event was reported as blood leakage: redo descending aortic replacement was performed on the patient with et (essential thrombocythaemia) who underwent the gelweave implantation on (b)(6) 2026.During the procedure, significant blood leakage from the gelweave was noted.Despite the administration of protamine, there was still significant leakage from the gelweave, making it difficult to achieve hemostasis.Although nearly two hours passed, hemostasis could not be achieved.Therefore, three surgiflo hemostatic matrix kits (johnson & johnson) were used, and a surgicel absorbable hemostat (johnson & johnson) was placed firmly on the bleeding site.Then, the chest was closed.Doctor's comment: blood leakage occurred from the gelweave implanted on (b)(6) 2026.Due to the difficulty of achieving homeostasis during the redo procedure because of the leakage, the applicability of gelweave for patients who will undergo a redo procedure must be considered.It would be difficult to use gelweave unless the cause of this event is identified because i will not be able to provide patients with reasonable explanations about the devices that will be used during the procedure.There was no health damage was reported after closing the chest.
Additional Manufacturer Narrative
Clinical code: 1888 - hemorrhage/blood loss/bleeding - event reported by the sight as blood leakage.Impact code: 4624 - surgical intervention -three surgiflo hemostatic matrix kits (johnson & johnson) were used, and a surgicel absorbable hemostat (johnson & johnson) was placed firmly on the bleeding site.Then, the chest was closed.Medical device problem: 1250 - fluid/blood leak: site reported significant blood leakage from the gelweave device.Component code: 4755 - part/component/sub-assembly term not applicable: type of investigation: 4109 - historical data analysis: four-year review was performed for gelweave > leakage > blood oozing > body / blank / unknown, this gave an occurrence rate of (b)(4).No trend identified requiring action at this time.Investigation findings: 3233 - results pending completion of investigation - investigation ongoing.Investigation conclusion: 22 - known inherent risk of device: gelweave_siena_ver5_eng states in serious adverse events section bleeding & leakage of plasma components.11 - conclusion not yet available: investigation ongoing.

• Brand Name: Gelweave Four Branch Plexus
• Common Device Name: Gelweave Plexus
• Manufacturer (Section D): Vascutek LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer (Section G): Vascutek LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R R; UK PA49RR
• Manufacturer Contact: laura allan ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA49R-R ; UK PA49RR
• MDR Report Key: 50470954
• Report Number: 9612515-2026-00058
• Device Sequence Number: 10176036
• Product Code: DSY
• UDI-Device Identifier: 05037881998459
• UDI-Public: 05037881998459
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73261088/10SA
• Device Lot Number: 26140853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown